Effect of Melatonin on Sleep Quality in Patients Dementia

NCT03066518 | Completed Phase 4 DMC

• 1 other identifier: GE15-002
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction: Patients with dementia may suffer from poor sleep quality. Disturbance in the metabolism melatonin may have a role in the pathogenesis of sleep-wake cycle alterations in dementia. Objective: To evaluate the efficacy of low dose exogenous melatonin in improving sleep quality. Design: A single-center randomized, double-blinded, placebo-controlled study carried out on outpatients with dementia and sleep alterations. Participants: The investigators calculated a 40 individuals aged 65 years or over with a diagnosis of mild-moderate dementia (Clinical Dementia Rating 1-2). Intervention: Patients were randomized to receive either 5 mg of melatonin or placebo every night for 8 weeks. Measurements: The primary outcome was sleep quality according to the Pittsburgh Sleep Quality Index (PSQI).

Conditions

Sleep Disorders; Dementia

Keywords

melatonin; sleep; dementia; cognition

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index

  A self-administered questionnaire that provides an overall rating of sleep quality.

  8 weeks

Secondary Outcomes (1)

• Minimental test

  baseline and to the 8 weeks

Study Arms (2)

Melatonin

PLACEBO COMPARATOR

Melatonin 5 mg, daily, eight weeks

Drug: Melatonin 5 mg

placebo

PLACEBO COMPARATOR

Placebo, daily, eight weeks

Other: Placebo

Interventions

Melatonin 5 mg DRUG

Also known as: Benedorm

Melatonin

Placebo OTHER

placebo

Eligibility Criteria

• Age: 60 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 60 years;
• Circadian cycle sleep disorder with insomnia (according to Diagnostic and Statistical Manual of Mental Disorders- V criteria);
• Mild or moderate dementia (clinical dementia rating 1 and 2);
• Medications such as anti-depressants, acetylcholinesterase inhibitors, antipsychotics or memantine were allowed as long as they were initiated for over 8 weeks.

You may not qualify if:

• They had other diagnoses of sleep disorders, known hypersensitivity to melatonin, use of stimulants or hypnotics, recent diagnosis (within 8 weeks) of mood disorders or neuropsychiatric symptoms.

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Related Publications (11)

• Crowley K. Sleep and sleep disorders in older adults. Neuropsychol Rev. 2011 Mar;21(1):41-53. doi: 10.1007/s11065-010-9154-6. Epub 2011 Jan 12.

  PMID: 21225347 BACKGROUND

• Neikrug AB, Ancoli-Israel S. Sleep disorders in the older adult - a mini-review. Gerontology. 2010;56(2):181-9. doi: 10.1159/000236900. Epub 2009 Sep 9.

  PMID: 19738366 BACKGROUND

• Beaulieu-Bonneau S, Hudon C. Sleep disturbances in older adults with mild cognitive impairment. Int Psychogeriatr. 2009 Aug;21(4):654-66. doi: 10.1017/S1041610209009120. Epub 2009 May 11.

  PMID: 19426575 BACKGROUND

• Woods DL, Phillips LR, Martin JL. Biological basis for sleep disturbance and behavioral symptoms in dementia: a biobehavioral model. Res Gerontol Nurs. 2011 Oct;4(4):281-93. doi: 10.3928/19404921-20110302-01. Epub 2011 Mar 16.

  PMID: 21417189 BACKGROUND

• Guarnieri B, Cerroni G, Sorbi S. Sleep disturbances and cognitive decline: recommendations on clinical assessment and the management. Arch Ital Biol. 2015 Jun-Sep;153(2-3):225-30. doi: 10.12871/0003982920152347.

  PMID: 26742676 BACKGROUND

• Ooms S, Ju YE. Treatment of Sleep Disorders in Dementia. Curr Treat Options Neurol. 2016 Sep;18(9):40. doi: 10.1007/s11940-016-0424-3.

  PMID: 27476067 BACKGROUND

• Xu J, Wang LL, Dammer EB, Li CB, Xu G, Chen SD, Wang G. Melatonin for sleep disorders and cognition in dementia: a meta-analysis of randomized controlled trials. Am J Alzheimers Dis Other Demen. 2015 Aug;30(5):439-47. doi: 10.1177/1533317514568005.

  PMID: 25614508 BACKGROUND

• McCleery J, Cohen DA, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2016 Nov 16;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub3.

  PMID: 27851868 BACKGROUND

• Chien MY, Chen HC. Poor sleep quality is independently associated with physical disability in older adults. J Clin Sleep Med. 2015 Mar 15;11(3):225-32. doi: 10.5664/jcsm.4532.

  PMID: 25515275 BACKGROUND

• Morales-Delgado R, Camara-Lemarroy CR, Salinas-Martinez R, Gamez-Trevino D, Arredondo-Jaime A, Hernandez-Maldonado E, Guajardo-Alvarez G. A randomized placebo-controlled trial evaluating the effect of melatonin on sleep quality in patients with mild-moderate dementia. Eur Geriatr Med. 2018 Aug;9(4):449-454. doi: 10.1007/s41999-018-0068-9. Epub 2018 May 24.

  PMID: 34674490 DERIVED

• McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.

  PMID: 33189083 DERIVED

MeSH Terms

Conditions

Sleep Wake Disorders; Dementia

Interventions

Melatonin; pyrithyldione

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Guillermo Guajardo, MD

  HUGonzález

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Selection for a treatment group was determined by a computer-generated randomization list, in a 1:1 ratio using the randomized permuted blocks method.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: A randomized, double-blinded, placebo-controlled study

Study Record Dates

• First Submitted: February 19, 2017
• First Posted: February 28, 2017
• Study Start: January 15, 2016
• Primary Completion: January 25, 2017
• Study Completion: January 25, 2017
• Last Updated: February 28, 2017

Record last verified: 2017-02